—#182662

Product

DePuy Synthes Trauma LCP One-Third Tubular Plate with Collar 8 Holes / 93mm - Product Usage: intended for fixation of fractures, osteotomies and non-unions of clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia and fibula, particularly in osteopenic bone. Part Number 241.381

FDA product code: HRS — Plate, Fixation, Bone
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K011335
Affected lot / code info: Lot Number: 29P6036 UDI: 10886982166913

Why it was recalled

May have one or more dimensional features out of tolerance includes: thread pitch diameter depth, thread minor diameter depth, plate thickness and end length out of tolerance that can potentially result in a reduced locking strength of an LCP screw

Root cause (FDA determination)

Process control

Action the firm took

DePuy Synthes issued Urgent Medical Device Removal letter dated July 21, 2020 stating reason for recall, health risk and action to take: Please take the following actions: 1. Immediately examine your inventory to determine if you have product subject to this action on hand and quarantine the subject product. 2. Complete the attached Verification Section (page 3 of this letter). Please include your facility name and address, account number, name of person completing the form, title, email address, telephone number and signature in the spaces provided. If you have product to be returned: " Call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number. " Return the completed Verification Section (page 3 of this letter) with the product to: Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132 " Send a copy of the completed Verification Section (page 3 of this letter) to DePuy Synthes by: Scan/email: RA-DPYCH-flactionint@ITS.JNJ.com " Return any subject product within 10 business days. If you have no product to be returned: " Return the Verification Section (page 3 of this letter) to DePuy Synthes by: Scan/email: RA-DPYCH-flactionint@ITS.JNJ.com 3. Forward this notice to anyone in your facility that needs to be informed. 4. If any of the subject product has been forwarded to another facility, contact that facility to arrange return. 5. Keep a copy of this notice visibly posted for awareness until the product subject to this action has been returned. While processing your returns, please maintain a copy of this notice with the product subject to this action and keep a copy for your records. Questions, please call 610-719-5450 or contact your DePuy Synthes Sales Consultant

Recalling firm

Firm: Synthes (USA) Products LLC
Address: 1301 Goshen Pkwy, West Chester, Pennsylvania 19380-5986

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2020-07-21
Terminated: 2022-02-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #182662. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.